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Photobiomodulation for postoperative pain relief following conventional periapical surgery: a randomised controlled study protocol

Por: Cirisola · R. W. C. · Moya · L. E. P. · Olazabal · M. V. G. · Wagmann · D. A. A. · Suarez · G. P. · Wince · C. · Bruno · M. L. H. · Salaberry · D. R. · Sobral · A. P. T. · Longo · P. L. · Motta · L. J. · Bussadori · S. K. · Duran · C. C. G. · Fernandes · K. P. S. · Mesquita-Ferrari
Introduction

Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.

Methods and analysis

A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.

Trial registration number

NCT05935306.

Diabetes self-management observational study investigating how CGM use impacts diabetes distress, glycaemia and functions as a technological substitute for hypoglycaemia awareness: a study protocol

Por: Nitschke · M. J. · Demir · C. · Brosen · J. M. B. · Tapager · I. W. · Norgaard · K. · Kristensen · P. L. · Pedersen-Bjergaard · U.
Introduction

Continuous glucose monitoring (CGM) provides real-time glucose data for people with diabetes. However, detailed knowledge of its use in daily life remains limited. We aim to investigate the interaction between people with type 1 diabetes (T1D) and their CGM data and the impact of the interaction on glycaemia and diabetes distress.

Methods and analysis

This is a two-centre observational study of adults (n=500) with T1D using FreeStyle Libre 2. Over a period of 14 days, participants will continue their regular CGM use, record insulin doses and timing with smart insulin pens, track activity and sleep with an activity tracker, log all food intake in the LibreLink app and answer questions about quality of life and hypoglycaemia two times per day. Before the study period, the participants will complete a survey of 11 validated questionnaires assessing diabetes distress, hypoglycaemia awareness and other patient-reported outcomes (PROs). After the study period, the participants will complete two additional questionnaires assessing diabetes distress and health literacy.

The collected data will be used in two substudies with the overall aims of:

Substudy 1: to investigate how CGM is used in practice and the impact of the interaction on diabetes distress and glycaemia.

Substudy 2: to investigate whether and how CGM functions as a technological substitute for impaired awareness of hypoglycaemia, focusing on alarm data.

Endpoints will include CGM metrics, alarm data and PROs.

Ethics and dissemination

The Danish Data Protection Agency approved the study (P-2024–15985), and the regional committee on health research ethics has granted an ethical waiver (H-24014662). All participants have signed written informed consent forms before participating. The results will be published in an international peer-reviewed scientific journal by the study investigators and shared via www.clinicaltrials.gov. Participants who agreed to receive information about the study will be sent the results after publication.

Trial registration number

ClinicalTrials.gov (NCT06453434).

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